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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name biuret (colorimetric), total protein
510(k) Number K852844
Device Name AMRESCO FLOW PAC TOTAL PROTEIN BIURET & BLANK CONC
Applicant
AMERICAN RESEARCH PRODUCTS CO.
P.O. BOX 21009
SOUTH EUCLID,  OH  44121
Applicant Contact TIMOTHY J BELCASTRO
Correspondent
AMERICAN RESEARCH PRODUCTS CO.
P.O. BOX 21009
SOUTH EUCLID,  OH  44121
Correspondent Contact TIMOTHY J BELCASTRO
Regulation Number862.1635
Classification Product Code
CEK  
Date Received07/05/1985
Decision Date 07/22/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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